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Prader-Willi Syndrome (PWS)-Pipeline Review, H2 2015

Prader-Willi Syndrome (PWS)-Pipeline Review, H2 2015


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Executive Summary

Prader-Willi Syndrome (PWS)-Pipeline Review, H2 2015

Summary

Global Markets Direct's, 'Prader-Willi Syndrome (PWS)-Pipeline Review, H2 2015', provides an overview of the Prader-Willi Syndrome (PWS)'s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Prader-Willi Syndrome (PWS), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Prader-Willi Syndrome (PWS) and special features on late-stage and discontinued projects.

Global Markets Direct's report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct's proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct's team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

The report provides a snapshot of the global therapeutic landscape of Prader-Willi Syndrome (PWS)

The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in the therapeutics development for Prader-Willi Syndrome (PWS) and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Prader-Willi Syndrome (PWS) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

A detailed assessment of monotherapy and combination therapy pipeline projects

Coverage of the Prader-Willi Syndrome (PWS) pipeline on the basis of target, MoA, route of administration and molecule type

Latest news and deals relating related to pipeline products

Reasons To Buy

Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Develop strategic initiatives by understanding the focus areas of leading companies

Identify and understand important and diverse types of therapeutics under development for Prader-Willi Syndrome (PWS)

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding Prader-Willi Syndrome (PWS) pipeline depth and focus of Indication therapeutics

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Prader-Willi Syndrome (PWS) Overview 7

Therapeutics Development 8

Pipeline Products for Prader-Willi Syndrome (PWS)-Overview 8

Pipeline Products for Prader-Willi Syndrome (PWS)-Comparative Analysis 9

Prader-Willi Syndrome (PWS)-Therapeutics under Development by Companies 10

Prader-Willi Syndrome (PWS)-Therapeutics under Investigation by Universities/Institutes 11

Prader-Willi Syndrome (PWS)-Pipeline Products Glance 12

Late Stage Products 12

Clinical Stage Products 13

Early Stage Products 14

Unknown Stage Products 15

Prader-Willi Syndrome (PWS)-Products under Development by Companies 16

Prader-Willi Syndrome (PWS)-Products under Investigation by Universities/Institutes 17

Prader-Willi Syndrome (PWS)-Companies Involved in Therapeutics Development 18

Alize Pharma SAS 18

Chong Kun Dang Pharmaceutical Corp. 19

Essentialis, Inc. 20

Ferring International Center S.A. 21

LG Life Sciences, Ltd. 22

P2D Bioscience 23

Rhythm Pharmaceuticals 24

Prader-Willi Syndrome (PWS)-Therapeutics Assessment 25

Assessment by Monotherapy Products 25

Assessment by Target 26

Assessment by Mechanism of Action 28

Assessment by Route of Administration 30

Assessment by Molecule Type 32

Drug Profiles 34

AZP-531-Drug Profile 34

Product Description 34

Mechanism of Action 34

R&D Progress 34

beloranib-Drug Profile 35

Product Description 35

Mechanism of Action 35

R&D Progress 35

betahistine hydrochloride-Drug Profile 38

Product Description 38

Mechanism of Action 38

R&D Progress 38

carbetocin-Drug Profile 39

Product Description 39

Mechanism of Action 39

R&D Progress 39

diazoxide choline CR-Drug Profile 40

Product Description 40

Mechanism of Action 40

R&D Progress 40

K-671-Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

OV-401-Drug Profile 43

Product Description 43

Mechanism of Action 43

R&D Progress 43

setmelanotide-Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

Small Molecule to Activate snRNP-N for Prader-Willi Syndrome-Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

Small Molecule to Antagonize Ghrelin Receptor for Prader-Willi Syndrome-Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

somatropin (recombinant)-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

Prader-Willi Syndrome (PWS)-Recent Pipeline Updates 49

Prader-Willi Syndrome (PWS)-Dormant Projects 56

Prader-Willi Syndrome (PWS)-Product Development Milestones 57

Featured News & Press Releases 57

Jun 04, 2015: Rhythm Initiates Two Phase 2 Clinical Trials of Setmelanotide in Rare Genetic Disorders of Obesity Caused by MC4 Pathway Deficiencies 57

May 28, 2015: Zafgen Completes Enrollment of U.S. Phase 3 Trial of Beloranib in Prader-Willi Syndrome 58

May 08, 2015: Zafgen Presents Positive Safety And Efficacy Data From Phase 2 Trial Of Beloranib In Severe Obesity And Proof Of Concept Trial In Prader-Willi Syndrome At ECO 2015 59

Mar 26, 2015: Essentialis Presents Results From the First Phase of Clinical Study PC025 Evaluating DCCR in the Treatment of Prader-Willi Syndrome at ACMG Annual Clinical Genetic Meeting 60

Mar 02, 2015: Alize Pharma launches Phase II clinical trial of AZP-531 in Prader-Willi syndrome 61

Nov 14, 2014: Essentialis To Present Clinical Update At The Annual Research Conference Of The Foundation For Prader-Willi Research 62

Oct 01, 2014: Zafgen Announces Initiation of Phase 3 Trial of Beloranib in Prader-Willi Syndrome 62

Jul 23, 2014: Essentialis Secures Foundation for Prader-Willi Research Grant to Help Advance DCCR in the Treatment of Prader-Willi Syndrome 63

Jul 10, 2014: Zafgen Granted Orphan Drug Designation in the European Union for Beloranib, a First-in-Class MetAP2 Inhibitor for the Treatment of Prader-Willi Syndrome 64

Jun 27, 2014: Essentialis Announces the Dosing of the First Patient in a Clinical Study of DCCR in Prader-Willi Syndrome 64

Appendix 66

Methodology 66

Coverage 66

Secondary Research 66

Primary Research 66

Expert Panel Validation 66

Contact Us 66

Disclaimer 67

List of Tables

Number of Products under Development for Prader-Willi Syndrome (PWS), H2 2015 8

Number of Products under Development for Prader-Willi Syndrome (PWS)-Comparative Analysis, H2 2015 9

Number of Products under Development by Companies, H2 2015 10

Number of Products under Investigation by Universities/Institutes, H2 2015 11

Comparative Analysis by Late Stage Development, H2 2015 12

Comparative Analysis by Clinical Stage Development, H2 2015 13

Comparative Analysis by Early Stage Development, H2 2015 14

Comparative Analysis by Unknown Stage Development, H2 2015 15

Products under Development by Companies, H2 2015 16

Products under Investigation by Universities/Institutes, H2 2015 17

Prader-Willi Syndrome (PWS)-Pipeline by Alize Pharma SAS, H2 2015 18

Prader-Willi Syndrome (PWS)-Pipeline by Chong Kun Dang Pharmaceutical Corp., H2 2015 19

Prader-Willi Syndrome (PWS)-Pipeline by Essentialis, Inc., H2 2015 20

Prader-Willi Syndrome (PWS)-Pipeline by Ferring International Center S.A., H2 2015 21

Prader-Willi Syndrome (PWS)-Pipeline by LG Life Sciences, Ltd., H2 2015 22

Prader-Willi Syndrome (PWS)-Pipeline by P2D Bioscience, H2 2015 23

Prader-Willi Syndrome (PWS)-Pipeline by Rhythm Pharmaceuticals, H2 2015 24

Assessment by Monotherapy Products, H2 2015 25

Number of Products by Stage and Target, H2 2015 27

Number of Products by Stage and Mechanism of Action, H2 2015 29

Number of Products by Stage and Route of Administration, H2 2015 31

Number of Products by Stage and Molecule Type, H2 2015 33

Prader-Willi Syndrome (PWS) Therapeutics-Recent Pipeline Updates, H2 2015 49

Prader-Willi Syndrome (PWS)-Dormant Projects, H2 2015 56

List of Figures

Number of Products under Development for Prader-Willi Syndrome (PWS), H2 2015 8

Number of Products under Development for Prader-Willi Syndrome (PWS)-Comparative Analysis, H2 2015 9

Number of Products under Development by Companies, H2 2015 10

Comparative Analysis by Clinical Stage Development, H2 2015 13

Comparative Analysis by Early Stage Products, H2 2015 14

Assessment by Monotherapy Products, H2 2015 25

Number of Products by Top 10 Targets, H2 2015 26

Number of Products by Stage and Top 10 Targets, H2 2015 26

Number of Products by Top 10 Mechanism of Actions, H2 2015 28

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2015 28

Number of Products by Top 10 Routes of Administration, H2 2015 30

Number of Products by Stage and Top 10 Routes of Administration, H2 2015 30

Number of Products by Top 10 Molecule Types, H2 2015 32

Number of Products by Stage and Top 10 Molecule Types, H2 2015 32

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Alize Pharma SAS

Chong Kun Dang Pharmaceutical Corp.

Essentialis, Inc.

Ferring International Center S.A.

LG Life Sciences, Ltd.

P2D Bioscience

Rhythm Pharmaceuticals

Prader-Willi Syndrome (PWS) Therapeutic Products under Development, Key Players in Prader-Willi Syndrome (PWS) Therapeutics, Prader-Willi Syndrome (PWS) Pipeline Overview, Prader-Willi Syndrome (PWS) Pipeline, Prader-Willi Syndrome (PWS) Pipeline Assessment


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